Radicle Science launches several blinded placebo-controlled clinical trials on rare cannabinoids with 10,000 participants in the first half of 2022 on the heels of completing 25 large-scale CBD studies in 2021.
SAN DIEGO, February 10, 2022–(BUSINESS WIRE)–Radicle Science, a transformative healthtech B-corp validating health and wellness products for the first time, will launch history’s first large-scale, blinded, placebo-controlled clinical trials on rare cannabinoids including THCV, CBN, CBG, and CBC, to study their effects on energy, focus, appetite, sleep disturbance, pain, stress, and anxiety. These unprecedented Radicle Discovery studies will involve more than 10,000 participants and are set to kick off in early 2022.
Radicle Science closed out 2021 with the ground-breaking completion of 25 randomized controlled trials (RCTs) of cannabinoid products, including history’s largest CBD RCT. The Radicle Real World Evidence (RWE) studies, involving over 7,000 participants, examined various formulations of CBD-containing products and their effect on key health outcomes across five domains including general well-being, quality of life, sleep quality, pain, and feelings of stress and anxiety.
RADICLE SCIENCE BREAKS NEW GROUND IN FIRST HALF OF 2022
Radicle Discovery: Looking forward and making history
In the first half of 2022, Radicle Science will continue to conduct rigorous clinical trials on CBD products for pain, sleep disturbance, stress, and anxiety, while also commencing history’s first blinded, randomized, placebo-controlled clinical trials on rare cannabinoids for various conditions such as:
Effect of CBG on stress, anxiety, pain, and sleep disturbance
Effect of CBC on pain, anxiety, and sleep disturbance
Effect of CBN on sleep disturbance, stress, anxiety, and pain
Effect of THCV on energy, focus, and appetite
Brands participating in various portions of the clinical trials include Columbia Care, Lord Jones, Open Book Extracts, Straight Hemp, Trokie®, and Wana Brands.
Co-founder and CEO of Radicle Science, Dr. Jeff Chen, MD/MBA, explains; “We are headed for exponential growth in 2022 as we prepare to study ten times more people than we did in 2021.”
People from diverse backgrounds, demographics, and ages are encouraged to sign up to participate in a Radicle study and be a part of history.
Radicle Science speaks: Sharing insights with the industry
Radicle Science is excited to share knowledge with consumers, regulators, manufacturers, and healthcare providers from the aggregate anonymized data across our studies and to join conversations surrounding the future of cannabinoid clinical research.
“We aim to support our mission of creating a movement that redefines the research paradigm and enables evidence-based decision making across the health and wellness industry, starting with cannabinoids,” says Chen.
Among the industry events that Radicle Science co-founders Dr. Jeff Chen and Pelin Thorogood will be speaking in early 2022 are:
Cornell University 2022 Predictions Dinner
Radicle ACES webinar, featuring special guests Gavin Chandler, CEO of Trokie® and Rosemary Mazanet, MD, PhD, CSO of Columbia Care
Council for Cannabis Federal Regulation (CFCR) March webinar
New York University Big Ideas: The Emerging Cannabis Industry
RADICLE SCIENCE YEAR IN REVIEW: HISTORICAL ACCOMPLISHMENTS
In 2021, Radicle Science worked with dozens of industry leading cannabinoid brands, studying more participants across these RCTs than all worldwide cannabinoid RCTs combined that year, resulting in over 2M health outcome data points.
Radicle ACES: History’s largest cannabinoid study
Radicle ACES (Advancing CBD Education and Science) is history’s largest longitudinal RWE study to determine the effectiveness of botanical products containing CBD. It encompassed nearly 3,000 participants and set new standards for expediency and cost by completing ten times faster and ten times cheaper than traditional clinical trials. Participating brands included ALTWELL, Columbia Care, Healer, Lord Jones, Maven Hemp, MD FARMA, Peels (a citrus-derived brand), Prospect Farms, PURAURA Naturals from Enhanced Botanicals, Rae Wellness, Trokie®, and Verséa Wellness. Radicle ACES employed validated, standardized health indices to gather real-world health outcomes from a highly diverse population. Initial findings indicated participants experienced a 71% improvement in their well-being, on average, across all the products.
“Our virtual, direct-to-consumer, crowdsourced approach enables Radicle Science to democratize access to rigorous studies, allowing us to serve diverse brands, from startups to multibillion dollar publicly traded companies,” says Pelin Thorogood, Co-founder and Executive Chair of Radicle Science. “We are also proud to provide verified products and personalized health reports free of charge to thousands of individuals across the country who participate in our studies.”
Radicle RRWS: Reaching rural populations through a 100% virtual approach
Many brands also underwent a Radicle Real World Sleep study (RRWS), an RCT which researched the effectiveness of orally ingestible CBD products for sleep. In total over 2,000 participants from diverse geographical areas in the U.S. participated across all of these RRWS studies, including 10% from hard-to-reach rural and semi-rural populations typically not represented in clinical studies. When Radicle Science anonymized and aggregated the data across all brands who underwent a RRWS study, researchers found that among participants with pre-existing sleep complaints, on average 65% experienced a clinically meaningful improvement in their sleep quality after taking one of the CBD brands. The RCT generated RWE insights for several industry leading brands including Cannafloria Wellness, CÜRE CBD Wellness, Our Treaty, RealSleep, Straight Hemp, Trokie®, and Vitaldiol.
“Trokie® has always been a brand focused on evidence-based cannabis applications. We’re first and foremost a brand dedicated to delivering high quality, effective products to support patient health goals,” says Gavin Chandler, CFA, Chief Executive Officer of Trokie®. “Without rigorous scientific investigations, applications for cannabis products that are not FDA-approved will remain unclear to clinicians and thus the patients they serve. Rigorous clinical trials are critical for establishing Trokie® products as exceptional tools for supporting patient health and wellness.”
The Radicle Team: Unparalleled expertise
After hiring their first employee in November 2020, the Radicle Science team has rapidly grown to include renowned experts and luminaries with over 50 advanced degrees. Q4 2021 additions include Chairman of the Advisory Board Peter H. Diamandis, MD, named one of Fortune’s “World’s 50 Greatest Leaders,” CTO Sheldon Borkin, PhD, former VP of Tech and Chief Security Officer of WebMD, and Chief Research Officer Emily Pauli, PharmD, former Director of Research at Clearview Cancer Institute.
To learn more about Radicle Science, visit the Radicle Resources page. Better yet, get on our list to participate in a Radicle trial and join the Radicle movement! You can also follow us on LinkedIn, Facebook, Instagram, and Twitter.
About Radicle Science
Radicle Science is a transformative healthtech B-corp offering the first ever scalable path to validate and predict the effects of health and wellness products, transforming them into democratized precision solutions for ailments or enhancement of human function. Radicle Science leverages a proprietary data analytics platform and a virtual, direct-to-consumer (D2C) clinical trial model to deliver objective health outcome data across diverse populations and conditions, at a fraction of the cost and time of traditional methods. Our Radicle Vision is a future where affordable, accessible, health and wellness products are trusted by patients, recommended by healthcare providers, reimbursed by insurance, and used as widely as pharmaceutical drugs.
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Michelle L. Shuffett, MD ([email protected])